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Pralsetinib: First Approval

Anthony Markham1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|November 2, 2020
PubMed

Insights

Pralsetinib is a new targeted therapy for RET-altered cancers. It has gained accelerated approval for non-small cell lung cancer and is under review for thyroid cancers.

Area of Science:

  • Oncology
  • Molecular Biology
  • Pharmacology

Background:

  • The rearranged during transfection (RET) proto-oncogene is implicated in various solid tumors.
  • RET alterations, including fusions and mutations, drive cancer growth in specific patient populations.
  • Targeted inhibition of RET represents a promising therapeutic strategy.

Purpose of the Study:

  • To summarize the key milestones in the development of pralsetinib.
  • To highlight the regulatory journey of pralsetinib for RET-altered cancers.

Main Methods:

  • Review of preclinical and clinical development data for pralsetinib.
  • Analysis of regulatory submissions and approvals.

Main Results:

  • Pralsetinib demonstrated efficacy in RET fusion-positive non-small cell lung cancer (NSCLC).
  • Accelerated approval was granted in the USA for metastatic RET fusion-positive NSCLC.
  • Regulatory reviews are ongoing for thyroid cancers (RET fusion-positive and mutation-positive).

Conclusions:

  • Pralsetinib is a significant advancement in targeted therapy for RET-driven malignancies.
  • The development of pralsetinib underscores the importance of identifying specific genetic alterations for personalized cancer treatment.

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